GlaxoSmithKline, the second-largest pharmaceutical company in the world and makers of many prescription and over-the-counter drugs has petitioned the FDA to classify weight loss claims for dietary supplements as ‘disease claims’.

Many believe that this is an effort by GlaxoSmithKline, makers of alli™, an over-the-counter weight loss drug, to quash competition from the dietary supplement weight loss industry.

Their petition is designed to accomplish this by making it illegal for dietary supplement products to make claims about aiding in weight loss, as by law supplements may not make claims about treating any disease. Many view this as another in a long line of legal attacks by the pharmaceutical industry on competing supplement products. Read the full petition by clicking here: (PDF 3.2 MB).

GlaxoSmithKline already has a questionable record of honesty. The FDA recently issued a warning to the company for not reporting safety results on its diabetes pill Avandia. Previously, the Senate Finance Committee found that GlaxoSmithKline intimidated and coerced a prominent critic of Avandia so that he would no longer speak critically of the drug. Just before that, it was alleged that the company systematically hid and manipulated data concerning Paxil-induced suicide in depressed adults.

Given the relative strength of the pharmaceutical industry, estimated at over $550 billion per year and rapidly growing, its political influence is significantly stronger than that of the dietary supplement industry. Protection of dietary supplements relies primarily on grassroots action from consumers concerned about protecting their rights and preserving access to safe products with few side-effects that often work as well or better than their drug counterparts.

Part of our mission at DSIB is to educate the public about issues related to dietary supplements. GlaxoSmithKline’s petition has huge implications for dietary supplements, and we feel that a negative ruling by the FDA could result in more attacks from pharmaceutical companies, and perhaps eventually the death knell for the dietary supplements industry.

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Lately we’ve heard quite a lot about how nutritional supplements, including antioxidant vitamins, are regarded by a few scientists as a great danger—or so we might gather from recent media coverage that has treated us to such fear-mongering headlines as “Potential for harm in dietary supplements”1, “Vitamin pills may do more harm than good”2 and “Why some popular pills might kill you”.3

The scientific review to which these sensationalistic stories refer was a meta-analysis in the Cochrane Database of Systematic Reviews4. A meta-analysis is supposed to be careful re-review of many studies whose results are pooled together.

The Cochrane Database meta-analysis, authored by Goran Bjelakovic and others, is an updated version of a review that originally appeared in the Journal of the American Medical Association5 that had been roundly criticized by scientists.

While 67 clinical trials were included in this new review, most people are not aware that 748 trials were excluded for a number of reasons, including 405 studies that failed to show anybody died.6

One could persuasively argue that the authors of this review only included studies which could be molded to support the viewpoint that antioxidant vitamins are dangerous.

Dr. Bjelakovic has made no bones about his skeptical attitude towards dietary supplements. In 2007, he co-authored an article in the Journal of the National Cancer Institute entitled: “Surviving Antioxidant Supplements”7 and has posted an article on a newspaper syndicate entitled “Do antioxidant supplements work?”8

While meta-analyses, when properly conducted, can be an insightful tool; when ill used they are subject to bias by those who hold pre-determined conclusions and are seeking a way to force studies into them.

A wide body of scientific evidence has established that taking antioxidant supplements—including vitamins C and E, beta carotene, selenium and zinc—can help reduce the risk of chronic disease.

That being said, we know that antioxidant supplements (and supplements, in general) are not magic bullets, but they can be an important complement to a healthful diet.

If one twists science to create worldwide distrust in healthful dietary supplements, then one is truly harming consumers.

An award-winning journalist, published author, and member of the prestigious American Society of Journalists and Authors (ASJA), Gormley has 20 years of experience in health-related media communications. He is a senior policy advisor for Citizens for Health (www.citizens.org), an advisory board member of the National Health Research Institute (NHRI)and a member of the Institute of Food Technologists (IFT). From 2006 to 2008, Gormley directed three leading health-food trade magazines for VRM Inc. He is perhaps best known for having served as the longtime editor-in-chief of Better Nutrition magazine (1995 to 2002) and for having founded Remedies magazine in 2006. A consumer health advocate and industry champion, Gormley has also been a frequent guest on television and national radio where he has spoken out on a variety of health and regulatory issues.

NEW YORK—Rising numbers of consumers around the world are turning to homeopathy as an effective system of natural medicine, according to a new report from Global TGI; however, there is still considerable divergence of opinion. According to Global TGI, the highest level of “trust” in homeopathic medicine was in India, at 62 percent, followed by Brazil (58 percent) and Saudi Arabia (53 percent). On the other end of the spectrum, only 15 percent of Britons and 18 percent of Americans said they trust in homeopathy.

According to the market research company, consumers who have faith in homeopathy are more likely to have suffered from chronic or recurrent conditions, the areas where homeopathy is typically used. For example, in the United States, homeopathy supporters are 57 percent more likely than average to suffer from eczema or psoriasis, 29 percent more likely to have asthma, and 22 percent more likely to suffer from allergies or hay fever.

I’m sure that like many of you, my awareness of the impending catastrophes that face our environment is heightened a notch every time I read or hear about the abuses our world has suffered at the hands of humans. With each new report, I’m reminded to use less energy, cut down on waste and improve my recycling skills to do my part in forestalling or preventing what perhaps may be the inevitable. I do my part hoping that the little improvements I make will some how be exponentially magnified by other caretakers who also feel a responsibility to Mother Earth. While I feel that am responsive to these warnings, the frequency in which they occur at times causes me to gloss over them as a crisis du jour as I go about my daily tasks. I’m certainly concerned about the ever-retreating glaciers and how their imminent demise will have far reaching effects on our environment, but because it’s not a part of my daily existence, it tends to get short shrift to other more pressing issues on my agenda. There are times, however, when a new issue a rises that commands your attention even though you’re many parts removed from the source.

That is how I felt when I learned that the venerable omega three 18/12 fish oil (a staple of the dietary supplement industry since the 1980’s) will no longer be as ubiquitous because the fish that are being harvested from the sea supposedly have lower DHA levels than their predecessors. As a result, many manufacturers will no longer use the 18/12 nomenclature but will instead apply a more generic 30% total omega three to describe their product. Why is this occurring? Is this an adaptation caused by environmental changes? Has a particular species been reduced that has affected the composition of the oil? No press has been given to it to my knowledge and people in the industry to whom I have spoken don’t seem to know for sure but it seems certain that the “old” 18/12 as we know it will soon be a rarer commodity in the not-so-distant future. Whatever the reason, I couldn’t help making a connection between our overburdened environment and the oil from these deep water fish. Perhaps I’m a little off base but could this be another signal that the world as we know it is slightly more off-kilter?

This fragility can be also expressed in the rising costs of other commodities that are staples of our industry. Colony Collapse Disorder (CCD) which has had a devastating effect on bee populations both here and abroad is affecting the price and availability of honey, royal jelly and bee pollen as diminishing bee populations mean less honey, fewer bees for pollination and a dwindling number of queen bees as the number of hives decline. The exact reason is unknown but pesticides, viruses, mites and even radio waves have all been implicated in the bee’s demise.

News of higher prices for Vitamin E and tocotreinols are also rooted in environmental issues ranging from the diversion of palm oil, a rich source of Vitamin E isomers and caroteniods, from food to diesel biofuel, higher energy costs and transportation. Unfortunately, we’re likely to see more of these issues emerge as a convergence of factors ranging from poor stewardship to climatic changes is made manifest. They’re simply just a little harder to ignore when they strike closer to home.

James Roza is Director of Product Development for Reliance Private Label Supplements. Mr. Roza is a certified nutritionist with twenty-five years experience in the natural products supplement industry. He also serves on the executive board of the Natural Products Foundation (NPF), a not-for-profit organization working to raise industry standards, and also served as Vice-Chair of the Natural Products Association (NPA) ComPli -standards committee. James also served as a US delegate on several Codex committees and chaired the AOAC Task Force on Dietary Supplements. In addition, Mr. Roza served two terms as a Trustee to the American Herbal Products Association and served numerous terms on the Citizens for Health Board of Directors.

Here is yet another study finding potential benefits of Omega-3's. This one indicates that they may help depressives, cutting depression rates as much as 50 percent, the same as some prescription antidepressants.

Michael Levin, founder of Health Business Strategies, has provided an interesting assessment of the recent AARP Public Policy Institute report ondrug price trends in his latest blog. He highlights the danger of run-away pricing made possible by the Medicare drug program and increasing use of prescription drugs, and also suggests an innovative approach to evaluating the use of dietary supplements in place of selected prescription drugs.

Michael's blog reinforces the findings of the latest DSIB study on the health impact and cost savings of selected dietary supplements. The study found that more than $24 BILLION could be saved by the U.S. government over the next five years through the effective use of just a few select dietary supplements. More than $24 billion! Please take a look at that important study.

I welcome your comments on this issue and look forward to hearing your opinions.

This story, posted on sciencedaily.com, is yet another example of a scientific study that found a link between a dietary supplement and better health. For additional studies, see our Supplements in the News section.

Okay, so $415 million later the Women’s Health Initiative (WHI) Dietary Modification Trial not long back proved what we in the health-food camp have already known for ages — that fat balance and fat quality are key in promoting health and reducing the risk of cancer and heart disease.

The biggest-ever study to look at whether a low-fat diet can lower the risk of cancer or heart disease — one involving nearly 49,000 women aged 50 to 79 who were followed for eight years — found that, overall, a low-fat diet had no protective effect against these diseases.

As Harvard’s Dr. Walter Willett pointed out to the Washington Post at the time, “This should be the nail in the coffin for low-fat diets.”

Maybe, but low-fat and non-fat were, after all, bright, shining beacons of hope from a medical/public-health establishment that has, over the years, produced a series of health intifadas against such erstwhile “evils” as butter (not bad for us in moderation), salt (no persuasive evidence that it’s bad for the heart) and later, of course: fat.

Although public health groups are now saying that they had already well abandoned the “fat is bad” mantra a long time ago, the truth is that, as recently as 2000, the National Cancer Institute (NCI) was issuing cheerleading recommendations for low-fat and high-fiber diets in its Action Guide for Healthy Eating:

“Much research in the last few years has shown that […] eating a healthy diet, low in fat, high in fiber […] may help to lower cancer risk.” The NCI’s related “Action List for Fat” calls for consumers to use reduced-fat or non-fat salad dressings, low fat and fat-free foods and, you guessed it, margarine.

Today, it is known that low-fat salad dressings ironically lead to more weight gain than do their full-fat counterparts since tons of the fat-deprived dressings are heaped on salads since these poor cousins don’t make people feel full.

In terms of high-fiber, a 2005 review of 13 studies that appeared in the Journal of the American Medical Association found that high-fiber diets did not reduce the risk of colon cancer. We also know today that traditional tub margarine is loaded in heart-unfriendly partially hydrogenated (trans) fats.

One danger of these findings about the failings of low-fat diets is that people may feel the converse is true — that we can eat fat (of any kind) in unlimited quantities. False — saturated and trans fats will always be unhealthful, yes, however supplementation with high-potency, purified omega-3 fats is very healthful (and always will be).

Another danger is that people might believe that all dietary advice is unreliable and bad, and that everything should be discounted, which would be very wrong.

Although it is too bad the study did not employ generous levels of essential fats from the Mediterranean Diet, which is rich in omega-9 fat (olive oil) and omega-3 fats (mainly from fish) rather than cutting down all fat, alas it did not.

As I wrote, in DHA—A Good Fat, in 1999, “A balance of fats is what’s critical. […] a balance which existed, by and large, prior to the cholesterol crazes and low-fat/fat-free mania” that began a few decades ago.

Take away? Let’s keep eating healthfully, exercising, and thoughtfully supplementing, while feeling just a wee bit smug that we were right all along.

[Adapted from an editorial that originally appeared in Remedies magazine]

An award-winning journalist, published author, and member of the prestigious American Society of Journalists and Authors (ASJA), Gormley — who heads up communications for Solgar Vitamin and Herb (www.solgar.com) — has 20 years of experience in health-related media communications. He is a senior policy advisor for Citizens for Health (www.citizens.org), a scientific advisory board member of the National Health Research Institute (NHRI) (http://www.naturalhealthresearch.org) and a member of the Institute of Food Technologists (IFT). Gormley has also served on the Natural Product Association’s (NPA) communications committee since 1996. Prior to joining Solgar, Gormley directed three leading health-food industry trade magazines for VRM Inc. He is perhaps best known for having worked as a scientific and regulatory affairs officer for Nutrition 21 from 2002 to 2006 and for having served as the longtime editor-in-chief of Better Nutrition magazine (1995 to 2002). A consumer health advocate and industry champion, Gormley has also been a frequent guest on television and national radio where he has spoken out on a variety of health and regulatory issues.

On September 27, 2007 President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). This blog explains the danger of one of the least-known provisions of the law.

This provision has the potential to make it very difficult to introduce new ingredients into dietary supplements or food. This could be detrimental to you, the consumer, making it difficult or impossible to provide you with the latest advances in dietary supplements or with new ways to supplement foods to make them more nutritious.

Because of this little-known clause in the law, the FDA could take the position that no dietary supplement ingredient on which a clinical trial has been conducted can be used in food without formal FDA approval. FDA officials have noted that a literal interpretation of the new statute could greatly inhibit the introduction of new dietary ingredients, as most such ingredients are subject to at least one “significant clinical investigation” prior to introduction to the market.

Although it appears that the FDA has not yet decided how it plans to proceed, it also appears that the FDA is considering this type of approach. Prior to making any final determination, the FDA is likely to seek consumer input on its course of action. It’s important for consumers to be ready to make their voices heard and preserve the current regulatory framework rather than this new, questionable regulation.

We’ll keep you informed on developments as they take place, so keep an eye on our site for up-to-date news on this important issue. Your rights as a consumer could potentially be at risk, so it’s important that you stay informed.

When I tell people I work with the Dietary Supplement Information Bureau, “Are supplements safe?” is one of the most commonly-asked questions, so for my first blog entry, I thought I’d tackle this issue. This is also one of the topics with the most misinformation being spread.

Unfortunately, many people think that dietary supplements aren’t regulated, which simply isn’t the case. Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA), although not like drugs, but instead like foods.

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which established new standards for dietary supplement products. Specifically, the FDA has the power to:

Stop any company from selling a dietary supplement that is "adulterated" or misbranded

Stop the sale of a dietary supplement that makes false or unsubstantiated claims

Take action against any dietary supplement that poses "a significant or unreasonable risk of illness or injury"

Stop any company making a claim that a product cures or treats a disease

The FDA assures that products are safe and accurately labeled, and dietary supplement manufacturers must notify the FDA of intended label claims and ensure that they can be substantiated.

The FDA has regulations on good manufacturing practices (GMPs) for dietary supplements. Under the rule, manufacturers are required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements.

In December 2006, Congress passed The Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “AER Bill”.) This legislation requires the reporting of “serious” adverse events for dietary supplements. Many people believe that over time this reporting requirement will provide additional proof of the safety of dietary supplements.

Studies have shown that prescription and over-the-counter drugs are responsible for over 100,000 deaths per year and millions of adverse reactions. In contrast, dietary supplements are much less likely to trigger adverse incidents. Dietary supplements have even been found to be far safer than foods! For more information on these findings, see our FAQ page by clicking here.

So if you’re wondering if dietary supplements are safe, the answer is yes, if used responsibly. However, as a consumer, you should be aware of what supplements and amounts you’re taking and how this may affect your health or interact with prescription or over-the-counter drugs. Make sure to read all labels, and if you have any questions or concerns, ask your professional healthcare provider. For more information, visit the lookup pages on this site for in-depth research and information on vitamins, supplements and herbs.

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